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Regulatory Executive (Labelling)

Middlesex   •  Contract/Temporary, Full time


CK Group are recruiting for a Regulatory Executive to join a company in the healthcare industry at their site based in Brentford on a contract basis initially for 12 months.

Salary:
£75.79 per hour Umbrella

Regulatory Executive Role:

  • Manage the development and maintenance of the Global Product Information for Prescribing/Patient/Packaging Information
  • Support regional and country product information (prescriber and patient), primarily in the EU and APJEM markets

Accountable for:

  • Authoring, development and maintenance of EU product information and Global Product Information (PI), in conjunction with functional experts.
  • Authoring of the patient information in the Global Patient Leaflet (GPL).
  • Generation of responses to regulatory agency questions related to prescriber and patient information.

Your Background:

  • Life sciences degree (Pharmacy preferred) or relevant experience, or PhD or equivalent relevant experience.
  • Relevant experience includes pharmacy practice, regulatory affairs, medical affairs, clinical research, or pharmacovigilance.
  • Excellent Scientific Regulatory Writing ? the ability to produce written regulatory scientific communications with clarity, accuracy and rigor.
  • Data analysis skills ? basic understanding of biostatistics, clinical trial design, and clinical therapeutics
  • Therapeutic / Product Knowledge. Will have knowledge of therapeutic area(s), particularly the HIV area, and be developing a sound knowledge of a product portfolio.
  • Regulatory Knowledge and basic understanding of policy and processes relating to management of prescriber, patient and pack information.

Company:
Our client is a global healthcare company, taking on some of the world\'s biggest healthcare challenges.

Location:
This Regulatory Executive role is home based with Covid restrictions are in effect but will then probably be based at our clients site in Brentford, Greater London.

Apply:

Please note that the successful applicant will be required to engage via an FCSA-accredited and CK-approved umbrella company and the rate of pay indicated is an umbrella rate.


You must be eligible to work in the UK. Learn more

  • Agency: CK Group
  • Contact: Heather Deagle
  • Phone: 0191 384 8905
  • Reference: 51015
  • Posted: 9th September 2021
  • Expires: 7th October 2021

CK Group

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